CLINICAL PREDICTORS OF MALIGNANCY IN FEMALE FILIPINO PATIENTS WITH A PALPABLE BREAST MASS
Abstract :
Objective : To come out with a reliable and simpler set of clinical predictors of malignancy in female Filipino patients with a palpable breast mass that will assist patients and their physicians in the formulation of a clinical diagnosis. Methods : This research is a prospective study of female Filipino patients with a palpable and dominant breast mass of at least 1 cm in its greatest diameter . Each patient is subjected to a physical examination to determine the character of the mass. Some patients are subjected to needle evaluation to determine the nature of the mass. All patients with a solid breast mass are subjected to either open biopsy or definitive treatment and histopathology results is used as the gold standard. Sensitivity, specificity, positive and negative predictive values and regression analysis are used for statistical analysis. Results : A total of 86 patients (56 for the non-malignant group and 30 for the malignant group) were included in the study. Age ranged from 22-65 years old while size of the breast mass ranged from 1x1 cm to 8x4 cm. Predictive values were computed for age, family history of breast cancer, border and fixation of the breast mass and the presence or absence of axillary lymph nodes. Sensitivity ranged from 20-55%, specificity at 60-100%, positive predictive value at 90-100% and negative predictive value at 0-60 %. Conclusion : The probability of malignancy increases when there is advanced age of the patient and when the breast mass presents with an ill-defined border, fixed and there is axillary lymph node.Benignity, on the other hand, is increased when there are no signs of malignancy and the nature of the breast mass is cystic. Family history, in the absence of signs of malignancy, is not a good predictor of breast cancer.
Key words : clinical predictors of malignancy; palpable breast mass
Introduction
There are a lot of female patients in the Philippines presenting with breast mass, which requires a clinical diagnosis as the first step in the management. The main concern of these patients as well as their attending physicians is whether the breast mass is malignant or not. In other words, the need of these patients and their physicians is information on the clinical predictors of malignancy in palpable breast masses. At present there are only a few published papers in the literature that deal with the clinical predictors of malignancy in palpable breast masses. These papers are all done abroad.
Despite the presence of published papers on the clinical predictors of malignancy in palpable breast masses in the world literature, the authors deem it necessary and worthwhile to conduct another study on the same topic in the Philippines. First of all, the authors deemed that there existed in the published papers other areas that needed to be explored further in order to come out with a more reliable and simpler set of clinical predictors. Second, conclusions in researches done in another community especially in another country with a different demography and culture are not always transferable and applicable in another community or another country.
The general objective of this paper is to come out with reliable and simpler set of clinical predictors of malignancy in female Filipino patients with palpable breast masses that will assist patients and their physicians in their formulation of clinical diagnosis.
The specific objectives consist of testing the predictive power for malignancy of the following data commonly looked for by physicians in their interview and physical examination: 1) age in the absence of ill-defined border and fixation of the palpable breast mass and a palpable axillary lymph node 2) family history of breast cancer in the absence of ill-defined border and fixation of the palpable breast mass and a palpable axillary lymph node; 3) ill-defined border of the mass alone; 4) fixation of the mass alone; 5) ill-defined border and fixation of the mass without a palpable axillary lymph node; 6) ill-defined border and fixation of the mass with a palpable axillary lymph node; and 7) presence of a palpable axillary lymph node in the absence of ill-defined border and fixation of the palpable breast mass.
The following data were also looked into as to their reliability as a physical examination finding and, if reliable, their predictive power for malignancy: 1) nature of the mass whether cystic or solid; 2) tenderness; and 3) consistency whether hard or non-hard.
Methods
Setting: Department of Surgery, Ospital ng Maynila Medical Center
Time of Study: January 1, 2005 to August, 2005
All female Filipino patients with a palpable and dominant breast mass, at least 1 cm in its greatest diameter and with or without any previous biopsy (needle and open) and treatment and without signs of inflammation were included in the study. Note: Patients who have mammography and ultrasound were also included.
Each patient was subjected to a physical examination by 3 examiners to get a consensus on the physical examination findings, border and fixation of the breast mass (and nature, consistency, and tenderness), and axillary lymph node.
The following clinical data were collected:
Age
Family history of breast cancer limited to mother, daughters, sisters, and first degree aunts
Size in cm assisted by a ruler
Border ill-defined or well-defined (see definition of terms)
Fixation fixed or not fixed (see definition of terms)
Nature of the mass whether cystic or solid (see definition of terms)
Consistency hard or not hard (not included in the study)
Tenderness - tender or not
Axillary lymph node present or absent palpable lymph node and size noted in cm
Some of the patients were subjected to needle evaluation. The needle evaluation affirmed right away the nature of the mass, whether cystic or solid. Macrocysts (cystic masses with nonsanguinous fluid and with complete disappearance upon needle aspiration) were considered non-malignant and no other procedures will be done. Masses with sanguinous fluid will be subjected either to further diagnostic or to a definitive treatment procedure after the needle evaluation and biopsy.
All patients with solid breast masses wiere subjected to either open biopsy or definitive treatment (excision, wide excision, and mastectomy) and the microscopic examination result (histopath) was used as the gold standard.
Statistics used were sensitivity, specificity, positive and negative predictive values.
Definition of Terms
Ill-defined border border of the palpable breast mass difficult to delineate from the adjacent breast tissue
Well-defined border border of the palpable breast mass easy to delineate from the adjacent breast tissue
Fixation adherent no matter how slight or minimal either to the overlying skin or underlying tissues
No fixation not adherent whatsoever both to overlying skin and underlying tissue
Cystic nature of the mass if the mass feels like it contains fluid because of its compressibility.
Solid nature of the mass if the mass does not feel cystic.
Hard consistency - if the consistency approximates the consistency of a bone.
Non-hard consistency if the consistency is not hard
Tender pain on any degree of pressure
Non-tender no pain whatsoever on light and firm pressure.
Results
A total number of 86 patients (56 for the non-malignant and 30 for the malignant) were included in the study. Under the non-malignant group, 5 patients had macrocysts, and 51 had fibroadenoma. On the other hand, all the patients under the malignant group had Invasive Ductal Carcinoma. Age ranged from 25 66 years old with a mean of 44.5. Size of the breast mass ranged from 1x1 8x4 cm with a mean of 3x2.5 cm
Table 1 shows the distribution of patients according to age group and whether they fall under the malignant or non-malignant group.
Table 2 shows the number of patients with and without family history of breast cancer in each group.
Table 3 shows the number of patients having an ill-defined border of the breast mass by physical examination.
Table 4 shows the number of patients having a fixed breast mass by physical examination.
Table 5 shows the number of patients with an ill-defined border and fixed mass without a palpable axillary lymph node by physical examination.
Table 6 shows the number of patients with an ill-defined border and fixed breast mass with a palpable axillary lymph node by physical examination.
Table 7 shows the number of patients with a palpable axillary lymph node without fixation of the breast mass and ill-defined border.
Discussion
The primary goal of this study is to assist the patients and physicians in predicting the nature of the palpable breast mass. Commonly used tools such as age, family history, presence of an ill-defined border, fixation of the mass and presence or absence of lymph node were validated in the study. Tenderness, consistency and nature of the mass are unreliable since their appreciation are subjective. Family history is not a good clinical indicator.
The probability of malignancy increases when there is advanced age of the patient and when the breast mass presents with an ill-defined border, fixed and there is axillary lymph node.Benignity, on the other hand, is increased when there are no signs of malignancy and the nature of the breast mass is cystic. Family history, in the absence of signs of malignancy, is not a good predictor of breast cancer.
Table 1. Predictive value of age in absence of ill-defined border and fixation of the breast mass and a palpable lymph node.
Age |
Malignant |
Non-malignant |
25 and below |
0 |
20 |
26-30 |
2 |
20 |
31-40 |
6 |
10 |
41 and above |
22 |
6 |
Sensitivity: 20
Specificity: 100
Positive Predictive Value: 100
Negative Predictive Value: 67
Table 2. Predictive value of family history of breast cancer in absence of ill-defined border and fixation of the breast mass and a palpable lymph node.
Family history |
Malignant |
Non-malignant |
Positive |
6 |
0 |
Negative |
24 |
56 |
Sensitivity: 20
Specificity: 0
Positive Predictive Value: 100
Negative Predictive Value: 30
Table 3. Predictive value of ill-defined border alone.
Border of breast mass |
Malignant |
Non-malignant |
Ill-defined border |
6 |
0 |
Well-defined border |
24 |
56 |
Sensitivity: 20
Specificity: 0
Positive Predictive Value: 100
Negative Predictive Value: 30
Table 4 . Predictive value of fixation alone.
Fixation of breast mass |
Malignant |
Non-malignant |
Fixed |
6 |
0 |
Not fixed |
24 |
56 |
Sensitivity:20
Specificity: 0
Positive Predictive Value: 100
Negative Predictive Value: 30
Table 5. Predictive value of ill-defined border and fixation of the mass without a palpable axillary lymph node.
Border and Fixation |
Malignant |
Non-malignant |
Ill-defined border and fixed |
30 |
32 |
Well-defined and Not fixed |
30 |
40 |
Sensitivity: 50
Specificity: 44
Positive Predictive Value: 48
Negative Predictive Value: 43
Table 6. Predictive value of ill-defined border and fixation of the mass with a palpable axillary lymph node.
Border and Fixation |
Malignant |
Non-malignant |
Ill-defined border and fixed |
0 |
0 |
Well-defined and Not fixed |
0 |
0 |
Sensitivity: 0
Specificity: 0
Positive Predictive Value: 0
Negative Predictive Value: 0
Table 7. Predictive value of a palpable axillary lymph node in the absence of ill-defined border and fixation of the palpable breast mass.
Palpable axillary lymph node |
Malignant |
Non-malignant |
Positive |
6 |
0 |
Negative |
24 |
56 |
Sensitivity: 20
Specificity: 0
Positive Predictive Value: 100
Negative Predictive Value: 30
References:
1. Osuch, J.R., Reeves, M.J., Pathak, D.R., Kinchelow, T.. BREASTAID: Clinical Results From Early Development of a Clinical Decision Rule for Palpable Breast Masses. Annals of Surgery. www.medscape.com
2. Laupacis,A., Lekar N., Stiel IG. Clinical Prediction Rules : A Review and Suggested Modifications of Methodical Standards. JAMA 1997. www.medscape.com
3. Haagenson, C. Physicians Role in the Detection and Diagnosis of Breast Disease. Diseases of the Breast, 3rd Ed. Philadelphia : WB Saunders; 1986.
4. Schwartz. Principles of Surgery, 8th Ed. Mc Graw Hills 2005
5. Cameron. Current Surgical Therapy 8th Ed. Mosby Inc. 2004
6. Mc Kellar. Prognosis and Outcomes in Surgical Disease. Medical
Publishing.1999